Phase 3
Completed N=262
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Source: ClinicalTrials.gov NCT00137969 ↗
Enrolled (actual)
262
Serious AEs
40.5%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period — 21; 14; 29; 11 Participants — p=0.4875
Summary
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period |
21; 14; 29; 11; 119; 63 | 0.4875 |
| SECONDARY Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period |
-5.8; -5.9 | 0.8230 |
| SECONDARY Number of Participants Who Achieved an MCR (Excluding PCR) |
21; 14 | 0.4318 |
| SECONDARY Number of Participants Who Achieved a PCR (Including MCR) |
50; 25 | 0.9069 |
| SECONDARY Number of Participants Who Achieved a BILAG C or Better in All Domains |
42; 24 | 0.5602 |
| SECONDARY Time to First Moderate or Severe Flare |
112.0; 126.0 | 0.8979 |
| SECONDARY Change in SLE Expanded Health Survey Physical Function Score From Baseline |
8.2; 4.1 | 0.1277 |
| SECONDARY Number of Participants Who Achieved an MCR in The ITT Population |
14; 9 | 0.6202 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of systemic lupus erythematosus (SLE).
- Active disease at screening.
- Stable use of one immunosuppressive drug.
- Use of an antimalarial drug.
- For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation.
Exclusion Criteria
- Unstable patients with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
- Active moderate to severe glomerulonephritis.
- Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.
- Lack of peripheral venous access.
- Pregnant women or nursing (breast feeding) mothers.
- History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude subject participation.
- Concomitant conditions that require oral or systemic corticosteroid use.
- Known human immunodeficiency virus (HIV) infection.
- Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics.
- History of deep space infection.
- History of serious recurrent or chronic infection.
- History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
- Active alcohol or drug abuse, or history of alcohol or drug abuse.
- Major surgery.
- Previous treatment with CAMPATH-1H antibody.
- Previous treatment with any B cell-targeted therapy.
- Treatment with any investigational agent within 28 days of screening (Day -7) or 5 half-lives of the investigational drug (whichever is longer).
- Receipt of a live vaccine within 28 days prior to screening.
- Intolerance or contraindication to oral or IV corticosteroids.
- Use of a new immunosuppressive drug prior to screening or change in dose of ongoing immunosuppressive drug prior to screening.
- Prednisone dose of ≥ 1 mg/kg/day prior to screening.
- Treatment with cyclophosphamide or a calcineurin inhibitor.
- Treatment with a second immunosuppressive or immunomodulatory drug.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x the upper limit of normal.
Data sourced from ClinicalTrials.gov (NCT00137969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.